PUMP MMT-1884XCU 780G MG CLIN US BLE2
Report
- Report Number
- 2032227-2023-251054
- Event Type
- Injury
- Date Received
- August 8, 2023
- Date of Event
- July 17, 2023
- Report Date
- November 1, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000618810
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- 003
Narratives
THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
THE PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT TEST AT .08725 INCHES. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUMP. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, OR FORCE SENSOR. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED BATTERY COMPARTMENT, AND PILLOWING KEYPAD OVERLAY. THE PUMP PASSED ALL FUNCTIONAL TESTING. HIGH BG ANOMALY IS NOT CONFIRMED. THE PUMP HISTORY FILE LISTS 145 BOLUSES ON THE EVENT DATE, 7/17/2023. PLEASE SEE BELOW FOR THE FIRST 10 BOLUSES LISTED ON THE EVENT DATE 7/17/2023: ON (B)(6) 2023 00:36:19.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: CL1 MICRO BOLUS (5). NORMAL BOLUS AMOUNT PROGRAMMED: 500 (0.05 U) BOLUS AMOUNT DELIVERED: 500 (0.05 U). ON (B)(6) 2023 00:41:19.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: CL1 MICRO BOLUS (5). NORMAL BOLUS AMOUNT PROGRAMMED: 500 (0.05 U) BOLUS AMOUNT DELIVERED: 500 (0.05 U). ON (B)(6) 2023 01:01:19.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: CL1 MICRO BOLUS (5). NORMAL BOLUS AMOUNT PROGRAMMED: 500 (0.05 U) BOLUS AMOUNT DELIVERED: 500 (0.05 U). ON (B)(6) 2023 01:51:21.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: CL1 MICRO BOLUS (5). NORMAL BOLUS AMOUNT PROGRAMMED: 750 (0.075 U) BOLUS AMOUNT DELIVERED: 750 (0.075 U). ON (B)(6) 2023 01:56:19.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: CL1 MICRO BOLUS (5). NORMAL BOLUS AMOUNT PROGRAMMED: 500 (0.05 U) BOLUS AMOUNT DELIVERED: 500 (0.05 U). ON (B)(6) 2023 02:01:21.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: CL1 MICRO BOLUS (5). NORMAL BOLUS AMOUNT PROGRAMMED: 750 (0.075 U) BOLUS AMOUNT DELIVERED: 750 (0.075 U). ON (B)(6) 2023 02:06:19.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: CL1 MICRO BOLUS (5). NORMAL BOLUS AMOUNT PROGRAMMED: 250 (0.025 U) BOLUS AMOUNT DELIVERED: 250 (0.025 U). ON (B)(6) 2023 02:31:19.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: CL1 MICRO BOLUS (5). NORMAL BOLUS AMOUNT PROGRAMMED: 250 (0.025 U) BOLUS AMOUNT DELIVERED: 250 (0.025 U). ON (B)(6) 2023 02:41:19.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: CL1 MICRO BOLUS (5). NORMAL BOLUS AMOUNT PROGRAMMED: 250 (0.025 U) BOLUS AMOUNT DELIVERED: 250 (0.025 U). ON (B)(6) 2023 02:46:19.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: CL1 MICRO BOLUS (5). NORMAL BOLUS AMOUNT PROGRAMMED: 500 (0.05 U) BOLUS AMOUNT DELIVERED: 500 (0.05 U). THERE WERE NO AUTO SUSPEND EVENTS ON THE EVENT DATE, 7/17/2023. PLEASE SEE BELOW FOR THE USER SUSPEND ON THE EVENT DATE, 7/17/2023: ON (B)(6) 2023 17:45:50 INSULIN DELIVERY STOPPED EVENT TYPE = 30. REASON FOR INSULIN DELIVERY SUSPENSION = USER SUSPENDED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED INSULIN PUMP KEEPS SHOWING LOW BG (BLOOD GLUCOSE) VALUE WAS 512 MG/DL. CUSTOMER REPORTED SENSOR WAS READING LOW AND CUSTOMER ATE CARBS. CUSTOMER WAS REPORTED INSULIN DELIVERY WAS NOT SUSPENDED DUE TO SG (SENSOR GLUCOSE) VS BG (BLOOD GLUCOSE) DIFFERENCE. SG VALUE FROM REPORTED EVENT WAS 50.00 MG/DL AND BG VALUE FROM REPORTED EVENT WAS 512.00 MG/DL AND DIFFERENCE IN VALUE BETWEEN SG AND BG WAS 462.00 AND DIFFERENCE BETWEEN SG AND BG NOT WITHIN THE TARGET RANGE. CUSTOMER DID NOT CONSUMED MEDICATION SUCH AS ACETAMINOPHEN, PARACETAMOL, OR HYDROXYUREA (ALSO KNOWN AS HYDROXYCARBAMIDE). INSULIN PUMP WAS USED WITHIN 48 HOURS OF THE REPORTED HIGH BG EVENT AND AUTO MODE/SMARTGUARD FEATURE ACTIVE AT TIME OF HIGH BG EVENT. TROUBLESHOOTING WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS UNKNOWN IF THE CUSTOMER WILL CONTINUE TO USE OF THE DEVICE AND THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1467003 | PUMP MMT-1884XCU 780G MG CLIN US BLE2 | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1884XCU | A000894134 | 000000763000618810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |